Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Completed · Phase 3
Conditions studied: Staphylococcal Skin Infection
In brief
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
Key facts
- Study ID
- NCT00107978
- Run by
- Cumberland Pharmaceuticals
- People needed
- 1035
- Starts
- 2005-02-01
- Expected to finish
- 2006-05-01
- Last updated by the study team
- 2019-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
- major abscess requiring surgical incision and drainage;
- infected burn (see exclusion criteria for important qualifications);
- deep/extensive cellulitis;
- infected ulcer (see exclusion criteria for important qualifications);
- wound infections
- Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
You may not qualify if…
- Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
- Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Where it is running
- Louisiana State University Health Sciences Center, Dept of Med/ER Med — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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